| CTRI Number |
CTRI/2026/03/106275 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
21/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of nerve blocks for Postoperative pain relief after carcinoma gallbladder surgery |
|
Scientific Title of Study
|
A Comparative Study of Preemptive External Oblique Plane Block and Subcostal TAP Block for Postoperative Analgesia in Radical Cholecystectomy: A Randomised Single-Blinded Prospective Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Trishagni Talukdar |
| Designation |
Fellow |
| Affiliation |
State Cancer Institute |
| Address |
Department of Oncoanaesthesia,
State cancer Institute,
Gauhati Medical College, Guwahati.
Kamrup ASSAM 781032 India |
| Phone |
9435308737 |
| Fax |
|
| Email |
mback106@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Jili Basing |
| Designation |
Assistant professor |
| Affiliation |
State Cancer Institute |
| Address |
Department of Oncoanaesthesia,
State cancer Institute,
Gauhati Medical College, Guwahati.
Kamrup ASSAM 781032 India |
| Phone |
9643549684 |
| Fax |
|
| Email |
jili.basing1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Trishagni Talukdar |
| Designation |
Fellow |
| Affiliation |
State Cancer Institute |
| Address |
Department of Oncoanaesthesia,
State cancer Institute,
Gauhati Medical College, Guwahati.
Kamrup ASSAM 781032 India |
| Phone |
9435308737 |
| Fax |
|
| Email |
mback106@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oncoanaesthesia,
State cancer Institute, Gauhati Medical college, Guwahati, India
Pin 781032 |
|
|
Primary Sponsor
|
| Name |
State cancer institute |
| Address |
Department of Oncoanaesthesia
State cancer institute, Gauhati medical college, Guwahati , India
Pin 781032 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Trishagni Talukdar |
State Cancer Institute |
5th floor, Ot complex,Department of Oncoanaesthesia Kamrup ASSAM |
9435308737
mback106@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Gauhati medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Subcostal transverse abdominis plane (TAP) block |
In sucostal TAP local anaesthetic is deposited between internal oblique and transversus abdominis muscle just below the costal margin under ultrasound guidance. |
| Comparator Agent |
External oblique plane block (EOPB) |
In EOPB local anaethetic is deposited between external oblique and intercostal muscles over the lateral abdominal wall under ultrasound guidance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 65 years
ASA physical status I or II
Scheduled for elective radical cholecystectomy for gallbladder carcinoma
Ability to provide written informed consent |
|
| ExclusionCriteria |
| Details |
Known allergy or hypersensitivity to amide local anaesthetics
Local infection at the block site
Coagulopathy
BMI more than 35
Chronic opioid use or history of substance use disorder
Cognitive impairment or communication barriers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain score in both the groups |
2, 6, 12, and 24 hours Postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total opioid consumption.
Time to first request for rescue analgesia.
Any conplications. |
Postoperative 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Radical cholecystectomy is the standard surgical treatment for gallbladder carcinoma, involving extensive dissection, subcostal incisions, and lymphadenectomy. This results in significant somatic and visceral pain, posing challenges for optimal postoperative analgesia.” In oncoanesthesia, effective pain control is vital not only for comfort but also to reduce complications, facilitate early recovery, and support immune function. Systemic opioids have traditionally been the mainstay for analgesia but are associated with several drawbacks: respiratory depression, ileus, sedation, delayed mobilization, opioid tolerance, and immunosuppression—all particularly concerning in cancer patients. Hence, modern cancer care emphasizes opioid-sparing Ultrasound-guided regional blocks have emerged as safer and more targeted alternatives. The subcostal TAP block, targeting T6–T9 nerves, provides anterior abdominal wall analgesia but lacks visceral coverage and has limited lateral spread. In contrast, the External Oblique Plane (EOP) block—a newer technique—targets T6–T12 lateral cutaneous branches, potentially offering broader dermatomal coverage. Its superficial location aids visualization and makes it safer in coagulopathic or anatomically altered patients—common scenarios in oncoanesthesia. Importantly, preemptive administration of these blocks can reduce central sensitization, lower opioid needs, and enhance recovery—core principles of Enhanced Recovery After Surgery (ERAS) in oncology. However, comparative data on EOP versus subcostal TAP blocks in radical cholecystectomy are scarce. This randomized, single-blinded prospective study aims to compare the analgesic efficacy, opioid-sparing effect, safety, and patient satisfaction of preemptive EOP and subcostal TAP blocks with 0.2% ropivacaine in radical cholecystectomy |